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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-017682-33 | EudraCT Number |
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Recent clinical studies in abdominal surgery have shown that the use of Xylocaine® parenterally intraoperative at plasma concentrations below the toxic threshold of 5 .mu.g / ml, had an analgesic effect and decreased postoperative morphine consumption.
This study aims to evaluate the activity of Xylocaine® and ketamine separately administered parenterally, in terms of postoperative morphine consumption and decrease incidences of postoperative chronic pain at 3 and 6 months after laparoscopic colectomy compared the placebo group.
The evaluation of the intensity of postoperative pain, hyperalgesia perished skin surface scarring) and pain perception threshold by Pain Matcher® confirm or not the predictive nature of these criteria in the occurrence of chronic pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xylocaine | Experimental | intravenous administration |
|
| Ketamine | Experimental | intravenous administration |
|
| isotonic saline serum | Placebo Comparator | isotonic saline serum intravenous administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xylocaine | Drug | Xylocaine is administered at a dose of 1.5 mg / kg for induction and then relay by syringe pump at a dose of 1.33 mg / kg / hour will be administered throughout the duration of the intervention and for 24 hours after the end of thereof, to obtain deemed effective plasma concentrations of the order of 0.5 to 5 mcg / mL. |
| Measure | Description | Time Frame |
|---|---|---|
| Morphine consumption | During the first 24 postoperative hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Morphine consumption | All 6 hours during the 48 postoperative hours. | |
| Numeric rating scale score | All 2 hours during the first 24 postoperative hours and all 6 hours during the 48 postoperative hours. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gilles Lebuffe, MD, PhD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU, Hôpital Claude Huriez | Lille | France |
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|
| Ketamine | Drug | Ketamine will be administered at a dose of 0.5 mg / kg and then relay by syringe pump at a dose of 0.05 mg / kg / hour for the duration of surgery and 24 hours after the end thereof. |
|
| isotonic saline serum intravenous administration | Drug |
|
| Electric nociception threshold measured by PainMatcher | All 2 hours during the first 24 postoperative hours and all 6 hours during the 48 postoperative hours. |
| Hyperalgesia of peri-scar (in cm²) with a von Frey filament (pressure of 10 grams | At 2 days after postoperative |
| Questionnaire Douleur de Saint-Antoine (QDSA) , | evaluation with validated scores for chronic and neuropathic pains | at 3 months, at 6 months |
| Questionnaire d'Evaluation des Douleurs Neuropathiques (QEDN), | evaluation with validated scores for chronic and neuropathic pains | at 3 months, at 6 months |
| Time physiological function recovery | Ability to drink, to eat, to urinate, to walk | During the first 24 postoperative hours |
| Duration of hospital stay | At 5 days after postoperative |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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